FDA Device recall Z-2122-2017

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000

FDA Device
Class II
terminated
Published 2017-05-31

On 2017-05-31 the FDA classified a Class II recall of CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000 by Cardiovascular Systems, citing cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 201….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2122-2017
Classification	Class II
Status	terminated
Initiated	2017-04-14
Published	2017-05-31
Last updated	2026-09-13 11:54 UTC
Company	Cardiovascular Systems
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI

Product

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

Reason

Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.

Identifiers

code_info	Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 11822… Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 118223 121782 123165 123489 123547 123808 123878 124088 124289 124925 124927 124989 125310 125347 125362 126696 126797 126925 127026 127155 127221 127348 127614 127742 127834 128001 128027 128132 128179 128326 129266 129303 132418 132839 132966 133231 133429 133759 133880 134057 134318 134534 134966 135199 135372 135791 135941 136729 136881 136883 137221 137361 137657 137862 138218 138462 138614 139049 139295 139621 140470 140606 142474 142596 142604 142909 143084 143213 143277 143335 143419 143553 143556 143806 144066 144276 144496 145536 145946 146051 146199 146337 146401 146518 146843 146999 147508 147530 148129 148169 148400 148712 148897 149117 149268 149527 150273 150285 150774 150831 151196 151228 151440 151635 151867 151994 152092 152178 152321 152389 152522

code_info

Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 11822…

Lot Number 92254 92693 106281 106282 106283 106284 106285 106286 106287 106288 106290 106543 118121 118223 121782 123165 123489 123547 123808 123878 124088 124289 124925 124927 124989 125310 125347 125362 126696 126797 126925 127026 127155 127221 127348 127614 127742 127834 128001 128027 128132 128179 128326 129266 129303 132418 132839 132966 133231 133429 133759 133880 134057 134318 134534 134966 135199 135372 135791 135941 136729 136881 136883 137221 137361 137657 137862 138218 138462 138614 139049 139295 139621 140470 140606 142474 142596 142604 142909 143084 143213 143277 143335 143419 143553 143556 143806 144066 144276 144496 145536 145946 146051 146199 146337 146401 146518 146843 146999 147508 147530 148129 148169 148400 148712 148897 149117 149268 149527 150273 150285 150774 150831 151196 151228 151440 151635 151867 151994 152092 152178 152321 152389 152522

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2122-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.